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Randomized Controlled Trial
. 2017 Jun 15;7(6):e015291.
doi: 10.1136/bmjopen-2016-015291.

Peripherally InSerted CEntral Catheter Dressing and Securement in Patients With Cancer: The PISCES Trial. Protocol for a 2x2 Factorial, Superiority Randomised Controlled Trial

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Free PMC article
Randomized Controlled Trial

Peripherally InSerted CEntral Catheter Dressing and Securement in Patients With Cancer: The PISCES Trial. Protocol for a 2x2 Factorial, Superiority Randomised Controlled Trial

Claire M Rickard et al. BMJ Open. .
Free PMC article

Abstract

Introduction: Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure.

Methods and analysis: Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED.

Secondary outcomes: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant.

Ethics and dissemination: Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published.

Trial registration: Trial registration number is: ACTRN12616000315415.

Keywords: Catheter obstruction; Catheter-related infections; Catheterization, Central Venous; Occlusive dressings.; Upper extremity deep vein thrombosis.

Conflict of interest statement

Competing interests: CMR’s employer has received on her behalf: unrestricted research and educational grants from: 3M, Adhezion, Angiodynamics, Bard, Baxter, BBraun, BD, Carefusion, Centurion Medical Products, Cook Medical, Entrotech, Flomedical, ICU Medical, Medical Australia, Medtronic, Smiths Medical, Teleflex; consultancies payments for educational lectures from 3M, Bard, BBraun, BD,Carefusion and Mayo, and expert reports from BD, ResQDevices and Smiths Medical. NM’s employer has received on her behalf: consultancy payments for educational lectures based on her research from Hospira and BD, and unrestricted research grants from Adhezion and BD. JW: Nil. NG’s employer has received on her behalf: unrestricted research grants from Baxter. RC’s employer has received on his behalf: unrestricted research and educational grants from: StratPHARMA. ALM: Nil. PM’s employer has received on his behalf: research grants from Celgene, Janssen and Hospira. PM is a member of Advisory Boards for Celgene, Janssen, Amgen and BMS. PM has received consultancy payments from Celgene and Amgen. AU’s employer has received on her behalf: unrestricted research and educational grants from Adhezion, Angiodynamics, 3M, Carefusion, Centurion Medical Products and BBraun; consultancy payments for educational lectures based on her research from 3M and BD. TK’s employer has received on her behalf: unrestricted research and educational grants from 3M, Angiodynamics, Centurion Medical Products and Baxter; consultancy payments for educational lectures from Angiodynamics and BD VC: Nil. LZ’s employer has received on her behalf: an unrestricted research grant from BD. MM: Nil. EL: Nil. MAC: Nil. SK’s employer has on her behalf received consultancy payments for educational lectures and unrestricted research grants from BD. EA’s employer has received on his behalf: unrestricted research and educational grants from: 3M, BD, Carefusion, Cook Medical, Flo Medical. Consultancy payments for educational lectures based on his research and clinical expertise from 3M, BD, Carefusion, Teleflex, Cook Medical and Flo Medical. DM: Nil. MCM: Nil. DP: Nil. MC’s employer has received on her behalf: unrestricted research and educational grants from BD, Baxter, 3M and Entrotech. GRB’s employer has received on her behalf: unrestricted research grants from 3M, BBraun and BD/Carefusion. Consultancy payments for educational lectures based on her research from Becton Dickinson and ResQDevices. MIC: Nil. AH: Nil. AC: Nil. EGP: Nil. No commercial entity had any role in the conception, design or funding of this study, or in the preparation of this manuscript.

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